Jobs at Aspen Pharma Group

About

Conduct in-process compliance to quality procedures, standards and specifications for value stream operations, Review and approve quality related activities for value streams, Identify and provide solutions to systematic issues, Review Annual Performance Quality Review (APQR) as well as related administrative tasks.

Responsibilities

Planning and Process

• Provide technical and operational input during drafting of plans and procedures specific to unit.

Process Compliance

• Execute day-to-day QA activities for value streams
• Identify systematic technical and process issues by reviewing CAPA requests and trends
• Systematic investigation of the root causes of identified problems and risks for corrective action or prevention
• Develop CAPA plans and change incidents to address process compliance
• Implement operational changes to SOPs and processes, in compliance with control processes
• Ensure deviations (planned/ unplanned) and concessions are documented, reviewed, and analysed; and recommend validation activities to be performed
• Execute change control process by ensuring changes are documented, reviewed and approved

Annual Performance Quality Review

• Review APQRs to assess production risks and quality of in-process control programs
• Review and analyse CAPA plans to assess impact on quality procedures and standards

Retention Sample Management

• Store and manage retention samples as per guidelines

In Process Quality Management

• Review and approve outcome of in-process internal inspections

Reporting

• Monitor the storage of documents on the soft and hard copy filing systems
• Maintain and update records and systems as required
• Provide information for reports on weekly/monthly basis, as required by superior
• Compile standardised reports and consolidate documents

Requirements

Grade: 9

Background/experience

• Bachelor’s degree (B Pharm) with 4-6 years’ related work experience, or Post Graduate Degree/ Post Graduate Diploma with 2-4 years’ related work experience
• Pharmaceutical manufacturing experience

Specific job skills

• Advanced understanding of the pharmaceutical manufacturing and corrective action programs
• Pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives

Competencies

• Information Gathering
• Interrogating Information
• Offering Insights
• Taking Action

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About

Ensure in-process materials and finished products comply with GMP guidelines, regulation, and in-house SOPs, Determine product release for use into the marketplace, Control of documentation in compliance with regulation and company policies and procedures as well as related administrative tasks.

Responsibilities

Planning and Process

• Implement and coordinate systems and procedures and make decisions within policies and procedures, or as authorised by superiors

Product Release

• Review batch documentation and production conditions to assess compliance to quality procedures, standards and product specifications
• Review and approve quality of new, in-process and released batches to assess compliance to quality control programs, product specifications, and GMP guidelines
• Approve and release production batches
• Execute batch release priorities in line with OTIF and planning schedule
• Ensure release requirements are met for finished products
• Determine disposition of in-process and finished products for clinical and commercial use
• Ensure changes/ deviations in production or quality control have been approved according to QMS
• Initiate tests/ checks/ inspections/ sampling to mitigate any risk associated with planned changes/ deviations
• Ensure production and QC documentation are completed in compliance with SOPs
• Monitor and audit compliance to regulatory and in-house standards with regards to current GMP
• Report observed deficiencies in process and follow up on corrective action
• Investigate systematic quality problems and develop preventative plans, in conjunction with Production
• Provide input into GMP-related training needs

Reporting

• Complete and consolidate standard documents
• File, archive and retrieve documents
• Maintain and update records and systems as required

Requirements

Grade: 9

Background/experience

• Bachelor’s degree with 2-4 years’ related work experience, or Post Graduate Degree/ Diploma with 1-3 years’ related work experience
• Pharmaceutical manufacturing experience

Specific job skills

• Comprehensive knowledge of pharmaceutical manufacturing and corrective action programs
• Pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives

Competencies

• Information Gathering
• Interrogating Information
• Meeting Deadlines
• Finalising Output
• Taking Action